Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards, well documented and acceptable for assessement.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1968
Report date:
1968

Materials and methods

Principles of method if other than guideline:
Method: other: BASF-Test
GLP compliance:
no
Test type:
standard acute method

Test material

Constituent 1
Chemical structure
Reference substance name:
Dimethyl sulphate
EC Number:
201-058-1
EC Name:
Dimethyl sulphate
Cas Number:
77-78-1
Molecular formula:
C2H6O4S
IUPAC Name:
dimethyl sulfate
Details on test material:
- Name of test material (as cited in study report): dimethyl sulphate
- Physical state: liquid

Test animals

Species:
rat
Strain:
other: US
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: US rats
- Age at study initiation: young adult animals were used
- Diet: ad libitum
- Water: ad libitum
- Acclimation period:

ENVIRONMENTAL CONDITIONS
no data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: tragacanth (polysaccharide)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: animals received emulsions of 0.5-20% test substance with tragacanth by oral gavage
- Amount of vehicle (if gavage): 25-1600 µl/kg bw
Doses:
25, 50, 64, 80, 100, 125, 200 and 1600 µl/kg body weight (corresponding to appr. 33.3, 66.5, 85.1, 106.4, 133.0, 166.3, 266.0 and 2128.0 mg/kg body weight assuming a density of 1.33 g/ml)
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: animals were observed and examined for clinical signs of toxicity at least daily
- Necropsy of survivors performed: yes; deceased animals and those sacrificed at the end of the observation period were necropsied
- Other examinations performed: clinical signs, body weight
Statistics:
LD50 was approximated

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 85.1 - < 133 mg/kg bw
Remarks on result:
other: 20/20 animals died in the 133.0 mg/kg body weight dose group, 9/20 (8 males) died in the 106.4 mg/kg body weight dose group and 3/20 (2 males) died in the 133.0 mg/kg body weight dose group.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 106.4
Sex:
female
Dose descriptor:
LD50
Effect level:
> 85.1 - < 106.4
Sex:
male
Dose descriptor:
LD50
Effect level:
> 106.4 - < 133.2
Mortality:
First deaths were noted 1 h after dosing. All deaths occurred within 24 hours (see Table 1). No deaths occurred in the 50 µl/kg-group within the 7-day observation period.
Clinical signs:
Restlessness, irregular and accelerated breathing was reported for all dose levels. Dyspnoe, convulsions, apathy, hunched posture was observed at 100 µl/kg and higher doses.
Gross pathology:
Section findings, not discriminated according to dose level: Gastrectasy, decomposition, terminal lung oedema.

Any other information on results incl. tables

Table 1: Mortality

 

Dose level

(µl/kg bw)

Mortality during the 7-day observation period

Males

Females

Total

1600

10/10

10/10

20/20

200

10/10

10/10

20/20

125

6/10

10/10

16/20

100

10/10

10/10

20/20

80

1/10

8/10

9/20

64

1/10

2/10

3/20

50

0/10

0/10

0/20

25

0/10

0/10

0/20

Applicant's summary and conclusion